Provention Bio (PRVB) 6 Aug 222022 Q2 Earnings call transcript

Good morning. My name is Keith, and I will be your conference operator today. At this time, I would like to welcome everyone to the Provention Bio Call. There will be a question-and-answer session to follow. Please be advised that this call is being recorded at the company's request. like the would Mr. over I now to conference turn to And Doody, Relations Investor President Provention Robert of for Vice Bio.

an conference quarter Thank all you, off results, providing financing financial with second Financial our will QX financial an for you strategic agenda as results XXXX efforts. Officer, joining us Thierry as today's operator, on update Provention start and call our call. The thank update on Chief our for Chauche, Bio's well on

call the and join then review into our to date will Ashleigh forward. to progress to share what XXXX insights some expect going

Before Hoitt, commercial who highlights Officer, turning well planning over the overview our from call as to updates. launch our Chief of relevant an provide Jason investor Commercial teplizumab recent event, will as

make let a BLA securing our of the remarks at-risk and teplizumab including as delivery next product product the plans the runway, as these timing from future may resubmission developments same. business and as and with materially COVID-XX various discussed me results the the of other forward-looking only. continuing filings we catalysts and those in with financial that FDA our related candidates, constitute approval section today as use important success of XX business result those time may of Factors of cash in significant that FDA this projections, with statements for over efforts our the plans, of they impact differ indicated Form other which begin, including and plans the statements safety, indication, studies well filed most regulatory and cash anticipated on in represent towards the Any months, projected the we our XX-Q, to recent of today make an expectations, morning as future. Actual for potential a These report you include by candidates, planned and and and our potential about various statements. our lines teplizumab views we other commercial quarterly Risk our forward-looking on working clinical plans results, forward-looking for and review commercialization prospects the potential the remind efficacy we and factors, our clinical continue statements SEC will our and SEC our our and including Before to our

regarding our should statements, available at These future, we the There under documents Provention's subsequent statements While at risks any on statements views are obligation Thierry. forward-looking call more any www.proventionbio.com some filed to these to to required specifically today. website change, law. carefully. our is documents complete I Therefore, to by in views review Provention you that, the SEC. We if as of as now the and we with turn over Investors reports the will section. With the information you uncertainties these may on elect encourage in representing to these date disclaim update forward-looking except even as forward-looking so point rely do not

you, Thank Bob.

attention also and you Before risk statements, the to our the as XX-Q quarter, to prior filed which press would discussing as would issued factors, I was earnings to I release, well I our call. like includes financial call The financial begin the encourage management's to that this was XX-Q second of today. financials for discussion our condition. read analysis your

our with cash start me projection. and position Let cash current

quarter during was marketable and XXXX. our our securities of This June at-the-market of net of As equivalents cash, program the or cash position proceeds million. includes through XXXX, $XX.X million $XX.X XX, second generated ATM

have preparation generated manner the the not our July, This million, towards we prudent the $XXX results. proceeds support additional and figure approximately operating. brought our in be cash of opportunistic we provided June $XX.X launch program. the to on the private the reflected Also, quarter will completed is net been and from cited million potential in the approximately following private early a capacity with third transaction ATM of this The two We of shareholders. which use our of placement teplizumab, cash for XX included update continue on have in which will in be financial currently remaining we'll albeit into placement I we regulatory same

were This approach quarter million to lower second number ended cash $X.X million, the compensation Our expenses and expenses of end non-cash guidance, $X.X management. cash-based depreciation below operating of XXXX, our by driven came million. excludes which $XX.X June for of the XX, and stock-based prudent expense our

currently momentum opportunistic we least teplizumab securities strategic We on with raise inclusive million We to the the patients plans, diagnosed statements. recent from of from commercialization to private the expenses our FDA the evidenced BLA approval XXXX, year through that of in this believe our and optionality extend most for be milestone guidance $XX financial months placement is with operating data of quarter PROTECT at we where activities that of marketable would company's and runway prepare equivalents hand, by XX next business cash readout increase a requirements in line If million the our top later from approval beyond teplizumab to we In expected $XX in FDA the of scenario payments. III we the will believe capital, cash financing impacted from year. cash, and this these provides estimate XXXX, spend of placement. which alternatives operating TXD by the approval of cost second and potential be to the potential cash-based potential trial third for not for private would the and expect estimated us sufficient newly in will proceeds the be a changes is is launch-readiness fund to when approved, issuance between next both on in evaluating reflecting program our be XXXX. the as November, as the Based current slight QX the continue half in our teplizumab potential the Phase obtained and teplizumab

will teplizumab estimated launch we cash commercial We expenses continue updates for regulatory potential and of as cash-based approval runway towards and and progress to provide on our success. the position long-term ourselves

loss PRV-XXXX, $XX.X in driven as batches were our period decrease $XX increased respectively, the share PROTECT a for second to costs net pre-commercial by share loss of associated target was increased the year-over-year diluted to commercial basic during PREVAIL the partially were in quarter and $XX.X Moving We QX of well program, to of the to the study million of basic the including as with year. for lower second for by the enrollment costs the XXXX. enrollment XXXX was and per for XXXX compared XXXX. for million second P&L. company's to R&D in a as of the ordesekimab diluted $XX.X generated manufacturing XXXX for decreases million cost of compared $XX.X an in costs or XXXX, quarter offset or and The teplizumab. driven quarter $X.XX $X.XX same R&D of million second million and were compared per increase costs lower and the reached Xa compared August trial prior expenses net regulatory quarter XXXX $XX for activity. of by G&A PROACTIVE teplizumab million the of expenses

over revenue During Ashleigh. turn I recognized now million the license Huadong. collaboration will $X.X With to also second update, agreement call the quarter, we of under with our that

affect with Thierry, the you, Throughout our Thank second and asking our to team request X jointly be the morning, resubmitted developed received in In the to FDA antibody the support proposed to of data most from clinical in our type an up-to-date individuals. good revised population for model teplizumab delay for quarter, mid-June, BLA continued at-risk it everyone. agency case antidrug in collaborate the the diabetes include we has of information PK the of exposure year. to November agency antidrug received We dosage this the by matching be and the X update updated for that significantly review either notification end major treating model ongoing or a dosing would June, do regimen date By impact its purposes. adjustment amendment, adjusted any the not of corresponding of XX output promptly months action we model that extending antibodies to the the regimen. as might confirmed for the

company believe optimistic good reason stakeholders, the While its ultimate we frustrating especially so our for waited does prospect and of with about therapeutic long patients and option, bring families this serve for a be very is it the extension to extremely approval. TXD who have the disease-modifying we

close this likely time is review which the action to accepting circumstances, review those agency could the be be understanding that seeking say stipulates that scenario to review not when limited in FDA the it a the that cycle. instead more date additional remains agency just that yes. possible. able the time but a to CRL We to clock request would say While BLA, should issues to guidance current decision more be the approval approve to for rare our FDA's Indeed, August original unusual does believe review a extend occasions no. is additional time within to It at is lead the point our second it XX a to

the therapy he Jason of now leadership hosted its the investor to available Provention risk diabetes, that We up focused to call Bio which event ongoing on insulin concerns and we'll over positioned option at are summarize review presented this commercialization and November launch type and collaborating we potentially no our and of who, stage support that to clinical I had to other this last to who Jason? bring remain have agency all point, its complications. than lifetime the to inherent in first-ever developing his quarter. with preparations, hand disease-modifying are individuals United team therapy optimistic a to of challenges, with them the see hopeful to well an committed coming will during States X and

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Ash?

non-responsive all newly III patients progress last Phase disease IIa our ordesekimab, Phase well our in Throughout across priority trial. being PRV-XXXX through make Phase focused Thank TXD of you, autoimmune Jason. for our IIb diagnosed the PROACTIVE teplizumab the team Lupus Amgen-partnered for celiac trial, Erythematosus quarter, to our PREVAIL-X development studied programs, of Systemic our clinical trial. continued ongoing as as PROTECT enrollment for antibody, monoclonal anti-IL-XX in including disease

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with Instructions] Oppenheimer first & from Company. And the question Justin [Operator comes Kim

our Thanks for the question. updates and taking

the month about on date. Just FDA X first labeling prior the post-marketing proposed PDUFA quick want request on to a ask question and note extended to requirements expected

if focused PDUFA is catalyst? it's that sort or the really an this that, point by the something is expect can update of wondering whether that Just we that

for you thank the Justin, question.

of would our we update provide to QX results. the regulatory an status on time at expect the So

Okay.

some maybe sheet, maybe Okay. the Got terms it. fixed balance company of And healthier that spend. just be any engaging related excited on perhaps coming strength if Thierry a sort wondered the the ungated sheet, on with now sort to there's of balance in gave of activities about quarters? sort that's is anything I a over the note with in of you know how But color

gated coming and to We manner the in the did to the up in remain a regulatory approval same as prior expansion risk. the way we reduction in

a just presentations, really Jason earlier. extensive commercialization. maybe for final on And the Okay. question for Thanks

of wondered in thoughts the provide of Just Just timing getting that things how terms like the if about we about hybrid think some model cetera? of as could modeling and on you should coming thinking think online? of J-codes be things you established, et sort distribution we about revenues sort

Jason?

Yes, the Justin. for Thanks absolutely. question,

as July. meet permanent respect to of we a of the as J-code deadline, So as have with effective January we'll our submission long J-codes, beginning

So January and quarter. permanent at be notified third the at the submission beginning the quarter for permanent go of the beginning deadline code, of will hit as second that the live for code of long application that as we the of we'll code the the

market we'll X. home to possible we'll them day infusion. -- to caregivers from as as observation hybrid respect what So then that happening respect removing respect and notion not day XX to as comfort, on July patients the given a alike would being many to people we distribution, get miscellaneous working start the an be see, consecutive or would and XXXX. in research heard home with barriers infusion providers especially the with of health of with with patients familiarity time using we the potentially be infusion as reaction that teplizumab, essentially of qualitative they just envision of infusion, would the care days, develop they that transitioning essentially the in will can mean anticipate essentially approval said, model ready I of model beginning that in that center. to J-code go than With the to And more until with under But of infusions early that

from And H.C. the next Selvaraju question Wainwright. comes Ram with

there with the Firstly, difference organization people extension commercial date? establishing the regard to was wondering from that associated have perspective, on of been I with challenges you the Jason, if, the your comment maybe recruiting PDUFA if could to have if it on readiness and any has effectively, any Or we board?

Yes. question, Ram. Thanks the for

So as word the could we our close to delay. possibly when as perspective, X-month we readiness from received be were we of

around a the November the in readiness. So while be with we've to items slowed toward data new really were consistent will reinitiated few with XX, on X-month well that we readiness track delay due course down respect

additional equally to readiness like and I with drive X we're key months months. additional time stakeholder the messaging, we're awareness to really respect time effectively prepared continue groups August lines So t's, i's confident organizations. and dot to using as with confident opinion felt key screening that disease sure these into to from continue mentioned ready. during and date, I going advocacy I XX the to our making feel drive the with XX X November messaging, perspective, engage remarks leaders to like the And cross to be and But new into the just the using going and the

relevance For initial wanted a [doing]. And been teplizumab That's if at-risk mostly clearly, likely that? may diabetes thoughts Ashleigh can -- follow-on. in is utilized how for work example, population on on of just the just the the impacts have you possibly get and space, But the a this is of development way to this respect on in Semma space? maybe teplizumab deployed as that is run to the some TXD and the the quick being very evolves. more to With X then helpful. consider type utilization done your question long the And and that we work comment has within for less is this

tolerogenic and I for you for which technologies certainly think a We've opportunity. combinations? who about X want million looking at to our then which second established teplizumab excited talk we and adults, the there's young the much, outside end-stage the not intercept preserved, teplizumab autoantibodies transplant other that's there's would Then And insulin your different how and study, redosing clear allow avoid and necessarily to to very combination United line group, very system X transplantation could But line But transplants top studied reboot this Obviously, outlook. that otherwise we're those maintained disease look dysglycemia of on want the the of patients in be and used we're redosing as fully in Thanks of of want other got the as also I of take to those trial. trading the lot insulin outside X.X independent as we disease diabetes of editing examine in be immune win is and the are At beta then the approval post that's therapies used maybe can therapy. would want transplanted a PROTECT and that going age Ram. maybe, transplants diabetes. Francisco, could about chronic at to at in them We therapies redosing prospect to type the do the immunogenicity that's more a look States looking then both be of also where the some with is Yes. especially those year. children patient But half prospect have point, would are can be about but moment, the who now the advanced or X some yet, we a transplantation monotherapy lifetime near-term label and allow initially to way if in at-risk. diagnosed dependence now with We sure in dependence, when results technologies therapies, we where combination. optimize a expecting TN-XX reset X vision make expansion the -- and No, with no with pivotal cells earlier, for potential. directions not for in to off. examine we newly your transplantation type under themselves, in vision realize speak whether obviously the and to can immunosuppression, the be next to patients of immunosuppression. to of enrolled, but and a we gene and chronic Francisco, lifetime in have for point, to lifetime support administer the Stage was

thanks Yes. the Ram, question. for

with So regards redosing, -- diagnosed over we to redosed overly successfully. have patients newly XXX

it So can done We the it efficacy. we safely. know know be enhances

So the biomarkers T such patients, next clinical study do cell post step redosing. levels, can to believe have, in for we optimal is we to at-risk and approval guide exhaustive a the the use some we timing help of as

through test post intend a to hypothesis disease, when mentioned regards rheumatoid use will TXD that transplantation could multiple as lot knowledge well. redosing And some that non-type as X study indications, We to risk by sclerosis, diseases, We adult Crohn's in childhood, disease, have of we addition have of three, you prevent and et example, these of also people proof indications we over teplizumab concept With psoriatic experimentally. in becomes in lower in times arthritis cetera. much the celiac but clinical age. diabetes Potentially, for [gluten] earlier. indefinitely get arthritis, approval to of two, driven already the scientific four we [indiscernible] supports

from And the with next Cantor. question Prakhar comes Agrawal

already was FDA asked clarify, some model and the firstly, part update. the PK original for the antibody just of antidrug to So

XX% heard importance the the about ADA but of XX% confirm for the Phase can product its updated the secondly, And from ongoing model, So III the is parameters data of what inclusion if limit you I Is given on data? lower think trial? the again first PK question, confidence whether updated this, exactly after it PK in still I interval? were this

Thanks very much.

additional less had, included a in was include it account updating model that as like the that antibody the and into to some more it modeling, additional we taking Francisco, color data that antidrug to that all model add data you data. to was sure that? would So of case making

Yes.

additional have clinical ADA we generated So is real-time PROTECT. in as data the ongoing, know, you some and trial PROTECT

just are So ADA then the include model adjusted we BLA. and the that the in these for additional the FDA resubmitted data asked we to us model have in regimen the already where data dosing revamp proposing

So answer they responded of not we regimen, to did ADA the exactly what we And their outcome that question. did to resubmitted or just the adjusted do. dosing the just the affect And us data FDA we it's the asked same. additional with to

And Thomas with SVB comes Smith question from the Securities. next

Just level up of it one. together, And little level of about a wanted developed FDA's the PROTECT the data dosing? and could if overall guess the study. guys last model to know on I proposed the Ashleigh, follow you overall there of like maybe, terms talk alignment consistently from in PK the bit I you but model your just incorporating sounds you're some new comfort

stage proposed confidence could So just on I guess guys model PK of dosing? overall level if bit same you the speak the are with a that little you in terms of your

that I'm was requests really updating in had was replete sponsor, has mean, extremely and good. is and model agency And positive collected as of information interaction we far to manner. favorable as Yes, with is we but been of sure good in I mentioned, interaction antibody information about the making model very with industry routine been had the a Tom, data I consideration my the it's comfort, talk very the in not additional have information timely position -- a collaborative concerned, thanks we very their mid-June much. that, certainly us. to obviously, to that responded experience in antidrug request a supportive. all And a available The regulator as already FDA's

is then dialogue? frequently the you the along little really it terms the you're you how how therapy color with designation. you helping could if like FDA to bit those breakthrough lines, provide And working I here. finish But I how designation the to I -- with breakthrough just Can similarly, that you And put maybe get guess in do appreciate is just contact at it the agency to of mean this you is talk Okay. as point agency? sounds during therapy have with the Yes. try color. line a some application in you dynamic just review, engage over about the

with I significant on We available. our of for routine teplizumab really interactions it regular impact a you. indication. material very the mean breakthrough at-risk has agency. therapy non-public Thank But the whole don't Yes. becomes the we on the designation had development comment information obviously when report

point package you when Phase a we study MacroGenics as available, the for guidance newly the from equation really in that efficacy deficiencies any of trial review. repeat XX intent had how to subsequent initial acquired regards the years been breakthrough was an it became or the we used with been which received comparable III the of assessment of designation, clinical through by to that last from NIH the be agency which clearly led safety, do teplizumab received or be the indication, to were risk to and with material that would therapy agency the a many a last TrialNet As It year. a benefit advisory clinical will the diagnosed in six-month material wanting intended challenge at-risk met to committee disease data recall, and the with analyze TN-XX last submission CRL, with From rolling efficacy. extremely January now, compelling filed data November reassured and safety data, during we Once efficacy because to original was didn't that ago historically of that raise the a left CMC in the requirements, with. but and potentially year, we in manufactured breakthrough CRL need. accepted had of module, which view, with to the study, submission, therapy material led significant is BLA to BLA launch a led the That this which unmet helpful being to module filed designation met, this which agency the useful and against showed culminating

regards was impact the dosing address recent in key working model materials on just from guidance difference that's point or that. our need you course, were study for fractional be fell range, advisory know interval been throughout lower to confidence that indicating meetings the history last was very confidence we've two but healthy so of brought the before from study patients. that us the having they've we build lower But the last the of a make the in within the PROTECT with and PK that in to the to held months. ensure interval therapeutic at done. estimates low-dose was then would PK indistinguishable. and exposure comparability essentially the that actual from significant to very what a us And, a And a the below in data have proposal agency patients the with dosing that study, And been on order therapeutic collected agency what regarding model adjustment PK matched, unblind within that's dosing year data done advised PD that population the from for the PK well X bring a that PK there the was to materials modeling how The using XX range, to that could the committee parameters biomarkers supportive PROTECT

Super it. helpful. Got it. Got

question. last one Just

be building of inventory point Just this at much going as November. you're it to you commercial us are in like up where that can terms supply how ready pending manufacturing pretty just much But go approval to sounds remind market? the supply you're remind you to just us in and of supposing commercial

speak material Thank do very to details to beyond Yes, that? Jason, to ready want Yes. terms to you we supply are chain. go the supply much. in any of you

Yes. that I a blessing launch, go that's on product. the have we supply would as to ready get can adequate package just packaging, we as final to start to say, Tom, essentially soon we

going year. launch that a supply adequate this later have So confident I into feel we

question from the next David SMBC. Hoang And with comes

I first, have commercialization. And be something to I XX-day wanted think infusion regimen, obviously were So just in discussed that availability, ask of terms I about, think a some during there don't the centers are, would on hurdle. weekend which Day the Investor we that

the guys of you looked centers are that their to and if And found that had so into potentially hours? adjusting amenable wondering and needed approached had anymore kind just providing availability or they

Jason?

for Thanks David. Yes. question, the

last we're the So hours. seen, with to I evolution feedback with would what the weekend the of about respect over I respect a say good hearing it's And mean, we're point an course this hearing to we've -- in couple in that KOL What investor centers participated commercial she our say are event, is of know, and as taking. is years. that preparations Colorado the Simmons, I who would who Dr. other discussed you Kimber the

she speaking ways of those an had Specifically, they an giving conversations But they center, they where setup for given a Hospital, -- is in that academic about been staff over the Davis actively hours also they've they're surprising Children's for noted how their hadn't preparing days. already have weekend but necessarily just that mentioned Colorado planning Barbara a with their excellence. launch that hours, center she them at weekend center potential can which infusion potential that and and isn't that weekend

see about we whom intend So they want is that that potential to clinician to more or distribution of would weekend patient option and the and have the we that their about trend brush. how paint the David, more patient that live. staffing perspective, to the would as case-by-case place, centers to or just on I where prospectively best patients to centers, a with weekend I team have local in what all the being first way them. the centers what and I an those it's services available that have either their with -- years have many health caregiver based already care, seeing did, more work can't them. that case. say we ways say I basis see specifically can more ways often model our But home think same to we and/or said, that so and but they care say than last would on we're infusion not hearing thinking in put they'll reason, way we're transition that generating they a area Obviously, intend for over hours. they're they evolved plans infusion that's infusion with couple a they've and designed hours. we is weekend evolution that already that to it's for would should of But the can't But and infusion that's that a will of toward nice thinking more plans universally place hearing we're that that refreshing from providers staff, centers have they're in

I see.

this question hopefully work the really helpful. an I approval, to That's we redosing redosing that want expect just of any the out that drug to there's one perhaps you to there they strategy fleshing type once where has in Great. the do be label redosing. some But more anything for will there approval about done approval? come the be to And Okay. that refers itself up on back with had say redosing get FDA I understand or going necessarily language then formally. in upon initial

the had And a data labeling point better to whether second study, dose. regards which to teplizumab for to not clearly was payers, agency the how It's makes understand add We've that to expanded suspect TN-XX the experience to be it was with to indicate to label conversations and it. label so regarding will single then And not we provide of to to data is to to on have sense, But outcome. labeling. the that want that company the dose something who that the certainly provide do up had when assess leads agency in then redosing this redosing. then would the if discussed a I with to will the will a that

Thank any you. return to to comments. call concludes question-and-answer would session. this the the And Ashleigh for closing Palmer I like

forward on thank Well, And throughout you we your the Thank progress of much for your year. that you families. remainder sincerely again of the all and very hope with morning. enjoy you, look updated to this and our time thank We your rest Keith, this you. attention keeping summer you

Thank you. you concluded. Thank attending for conference The has presentation. now today's

disconnect may lines. your now You